Oracle Argus Safety. Service Administrator s Guide Release E

Transcription

1 Oracle Argus Safety Service Administrator s Guide Release E January 2011

2 Oracle Argus Safety Service Administrator's Guide Release E Copyright 2009, 2011 Oracle and/or its affiliates. All rights reserved. This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited. The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing. If this software or related documentation is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, the following notice is applicable: U.S. GOVERNMENT RIGHTS Programs, software, databases, and related documentation and technical data delivered to U.S. Government customers are "commercial computer software" or "commercial technical data" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, the use, duplication, disclosure, modification, and adaptation shall be subject to the restrictions and license terms set forth in the applicable Government contract, and, to the extent applicable by the terms of the Government contract, the additional rights set forth in FAR , Commercial Computer Software License (December 2007). Oracle USA, Inc., 500 Oracle Parkway, Redwood City, CA This software is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications which may create a risk of personal injury. If you use this software in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure the safe use of this software. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software in dangerous applications. Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other names may be trademarks of their respective owners. This software and documentation may provide access to or information on content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services.

3 Contents Preface... v About This Book... Documentation Accessibility... Related Documents... Conventions... v v vi vii 1 Argus Safety Service Process Overview 2 Argus Safety Service Configuration Configuring Site Printers Site Specific Dialog Box Fields and Field Descriptions Adding or Modifying an AG Service Process Argus Safety Process Configuration Understanding the User Interface Argus Process Dialog Box Fields and Field Descriptions Understanding Tasks Task Descriptions Configuring Argus Safety Process iii

4 iv

5 Preface This book describes the Argus Service process, including Safety Service configuration and Safety Process configuration. About This Book This manual contains four chapters: Chapter 1, "Argus Safety Service Process Overview" This section provides a general overview of the Argus Safety Service process. Chapter 2, "Argus Safety Service Configuration" This section provides information about configuring Argus Safety Service. Chapter 3, "Argus Safety Process Configuration" This section provides information about configuring Argus Safety Process. Documentation Accessibility Our goal is to make Oracle products, services, and supporting documentation accessible to all users, including users that are disabled. To that end, our documentation includes features that make information available to users of assistive technology. This documentation is available in HTML format, and contains markup to facilitate access by the disabled community. Accessibility standards will continue to evolve over time, and Oracle is actively engaged with other market-leading technology vendors to address technical obstacles so that our documentation can be accessible to all of our customers. For more information, visit the Oracle Accessibility Program Web site at Accessibility of Code Examples in Documentation Screen readers may not always correctly read the code examples in this document. The conventions for writing code require that closing braces should appear on an otherwise empty line; however, some screen readers may not always read a line of text that consists solely of a bracket or brace. Accessibility of Links to External Web Sites in Documentation This documentation may contain links to Web sites of other companies or organizations that Oracle does not own or control. Oracle neither evaluates nor makes any representations regarding the accessibility of these Web sites. v

6 Access to Oracle Support Oracle customers have access to electronic support through My Oracle Support. For information, visit or visit if you are hearing impaired. Related Documents This section lists the manuals for all Oracle Life Sciences products. You can order printed manuals from the Oracle istore. From the istore, search for the part number in parentheses. Oracle Argus Documentation The Oracle Argus documentation set includes: Oracle Argus Installation Guide (E15951) Oracle Argus Interchange User's Guide (E15946) Oracle Argus Affiliate User's Guide (E15947) Oracle Argus Safety Console User's Guide (E15950) Oracle Argus Safety User's Guide (E ) Oracle Argus Safety End of Study Unblinding User's Guide (E15956) Oracle Argus Dossier User's Guide (E15945) Oracle Clinical Documentation The Oracle Clinical documentation set includes: Oracle Clinical Installation Guide E15951) Oracle Argus Interchange User's Guide (E15946) Oracle Argus Affiliate User's Guide (E15947) Oracle Argus Safety Console User's Guide (E15950) Oracle Argus Safety User's Guide (E ) Oracle Argus Safety End of Study Unblinding User's Guide (E15956) Oracle Clinical Documentation The Oracle Clinical documentation set (A83790) includes: Oracle Clinical Administrator's Guide (A83791) Oracle Clinical Getting Started (B12308) Interfacing from Oracle Clinical (A83793) Oracle Clinical Conducting a Study (A85201) Oracle Clinical Creating a Study (A85200) Oracle Clinical Installation Guide (A83779) Oracle Clinical NLS Option Documentation The Oracle Clinical NLS Option documentation includes: Oracle Clinical NLS Option User Guide (A90473) vi

7 Oracle Thesaurus Management System (TMS) Documentation The TMS documentation includes: Oracle Thesaurus Management System User Guide (A82842) Oracle Thesaurus Management System Installation Guide (A83780) Oracle Adverse Event Reporting System (AERS) Documentation The Oracle AERS documentation set (B10328) includes: Oracle Adverse Event Reporting System Administrator's Guide (B10330) Oracle Adverse Event Reporting System Installation Guide (B10331) Oracle Adverse Event Reporting System User's Guide (B10329) Oracle Adverse Event Reporting System Quick Guide (B14419) Oracle Clinical Remote Data Capture (RDC) Documentation The Oracle RDC documentation includes: Oracle Clinical Remote Data Capture Classic Data Entry User's Guide (B13921) Oracle Clinical Remote Data Capture PDF Data Entry User's Guide (B139201) Oracle Clinical SiteMinder Documentation The Oracle Clinical SiteMinder documentation includes: Oracle Clinical SiteMinder User Guide (B15643) Oracle Clinical SiteMinder Installation Guide (B15645) Oracle Clinical TrialMinder Documentation The Oracle Clinical TrialMinder documentation includes: Oracle Clinical TrialMinder User Guide (B15644) Oracle Clinical TrialMinder Installation Guide (B15646) In addition, Oracle Health Science Global Business Unit (HSGBU) publishes PDF-format Technical Reference Manuals (TRMs) containing proprietary information on internal tables and APIs. If you are a licensed customer, contact Oracle Support to obtain a free electronic copy. This is a list of the available TRMs: Oracle Clinical Stable Interface TRM (A83796) Oracle Thesaurus Management System TRM (A82841) Oracle Adverse Event Reporting System Saved Queries TRM (B10353) Oracle Adverse Event Reporting System Reports TRM (B10352) Oracle Adverse Event Reporting System Edit Checks TRM (B10355) Conventions The following text conventions are used in this document: Convention boldface Meaning Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary. vii

8 Convention italic monospace Meaning Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values. Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter. viii

9 1 1Argus Safety Service Process Overview The flowchart below depicts the sequence of steps that should be followed to configure Argus Safety Service: The following table describes each of the steps shown in the flowchart above. Task Configuring Site Printers Understanding Tasks Configuring Argus Safety Process Description Specify printers to be used for different sites. Ensure that Argus Safety has been configured so that the Argus Safety Service processes can be configured. Refer to the Argus Console User Guide for details on configuring Argus Safety. Specify details for scheduling Argus Safety Service processes. Argus Safety Service Process Overview 1-1

10 1-2 Oracle Argus Safety Service Administrator's Guide

11 2 2Argus Safety Service Configuration Argus Safety Service configuration is done from the Argus Safety Service configuration utility. Note: Before starting Argus Safety Service, ensure that the service has been installed and at least one process has been configured. Refer to the Argus Safety Solution Components Installation Guide for information on starting Argus Safety Service. 1. To open this configuration utility, go to Start>Programs>Oracle>Argus Safety Service Configuration. 2. The Argus Safety Service dialog opens. This dialog enables you to configure site printers (refer to Configuring Site Printers), create new Argus Safety Processes and view existing Argus Safety Processes. Configuring Site Printers Use the following procedure to configure the site printers. To configure the site printers 1. Click Site in the Argus Safety Service dialog. Argus Safety Service Configuration 2-1

12 Configuring Site Printers 2. The Site Specific dialog opens. 3. Ensure that the Log Directory information is correct. 4. Click Add Printer to add a printer for the site. 5. Under Site, enter the country code of the site. Ensure that the country code is the same as the one in Argus Safety List Maintenance. 6. Select a row displaying a printer and click Delete Printer to delete it. To edit an existing site name, select the row corresponding to the site name and after a few seconds, click the site name. To change the printer assigned to a site, double-click the row corresponding to the site. 7. Click OK to confirm the settings. Note: You can configure multiple printers for the same site which can be populated within the Bulk Reporting dialog when you print the report to a specific printer. If a site-based printer is not defined for a particular site, the reports for that site are printed on the default printer on the Argus Safety Service machine. Site Specific Dialog Box Fields and Field Descriptions The following table describes the fields in the Site Specific dialog. Field Log Directory Site Printer Name Printer Database Browse Description Enables you to specify the path that will store the AG Service log files through the Browse button. Displays the full name of the site for which the printer is configured. Displays the name of the configured printer. Displays the full path of the configured printer. Enables you to select a database instance for the defined site printers. Enables you to specify the path in Log Directory to store the AG Service log files. 2-2 Oracle Argus Safety Service Administrator's Guide

13 Adding or Modifying an AG Service Process Field Add Printer Delete Printer Description Enables you to add a printer. Enables you to delete a printer selected from the Site Printers grid. Adding or Modifying an AG Service Process Use the following procedure to configure an AG Service Process for epsur notification: 1. Launch the AG Service Configuration application from Start>Programs>Oracle>Argus Safety Service Configuration. 2. The Argus Safety Service dialog appears. 3. Right-click Add Argus Process to enable or disable a process. Argus Safety Service Configuration 2-3

14 Adding or Modifying an AG Service Process Note: Disabling a process prevents Argus Safety Service from running that process when the service is restarted. A disabled process is depicted by a red icon before the Process Name. 4. Double click Add Argus Process to open the Argus Process dialog box. 5. Click Enable to enable or disable AG Service Processes. 6. If a process fails, the system sends an notifying the person whose mailing address is specified in Address. 7. Click OK to save the configuration to the process file. 8. Select epsur Notification from the Task list box and fill in other necessary information. 2-4 Oracle Argus Safety Service Administrator's Guide

15 3 3Argus Safety Process Configuration Argus Safety Service is a Windows process that automatically performs the tasks related to the Argus Safety Solution Components. The Administrator can configure Argus Safety Service to perform these tasks at specific intervals of time. Argus Safety processes can be configured using the Argus Process dialog shown in the following illustration. Argus Safety Process Configuration 3-1

16 To configure the Argus Safety process: 1. To open the Argus Process dialog for a new process, double-click Add Argus Process in the Argus Safety Service dialog. 3-2 Oracle Argus Safety Service Administrator's Guide

17 Understanding the User Interface 2. To open the Argus Process dialog for an existing process, right-click the process in the Argus Safety Service dialog and select Properties. Note: Understanding the User Interface You can create Argus Safety processes configure existing processes from the Argus Process dialog box. Argus Safety Process Configuration 3-3

18 Understanding the User Interface Argus Process Dialog Box Fields and Field Descriptions Item Name Process Task Start Time Interval Description Enter the name of the Argus Safety Process. Browse to the Argus Safety Service Installation folder and select the AGProc.exe file. Select the task to run that is associated with the Name entered in the first field. Enter the Initial Start Time for the Process. After the initial starting, the process will follow the Interval set in the next field. If Start Time is not selected, the process will begin immediately after starting the service. Enter the frequency at which the process will be executed. 3-4 Oracle Argus Safety Service Administrator's Guide

19 Understanding the User Interface Item Suspend Low Water Mark Enable User Name Password Confirm Address If a process is running for a period that is longer that what is specified in this field and the memory consumption of the process is below the Low Water Mark specified in the next field, then the process will be terminated. Default for 5 Minutes is the ideal setting and should not be changed. The Low Water Mark setting works with the Suspend field above. The Default setting of 200 is ideal and should not be changed. Allows you to enter an address in case a process fails. Enter in the Argus Safety Service User name that the process will connect to the system as. These users should be configured before using this utility. Each Process requires its own user configured to run. Enter the password that has been configured for the user entered above. Re-enter the password that has been configured for the user. If a process fails, an is sent to the address specified in this field. Documentum (Note: This section is enabled only if Document Report Push is selected in the Task list) User Name Password Docbase Domain Expedited Reports Cabinet Periodic Reports Cabinet Enter the Documentum user name that AG Service will use to connect to Documentum. Enter the password for the Documentum user. Enter the Docbase from the Documentum server. Enter the domain that the Documentum service is on. Enter the cabinet where Expedited Reports will be stored in Documentum. Enter the cabinet where Periodic Reports will be stored in Documentum. Documentum Type to Enter the Documentum table to store the report in. Push Fax (Note: This section is enabled only if Fax or Fax Status is selected in the Task list) Right Fax Fax Senior Server Port Network Dir Local Dir Notify RF Login Description Select Right Fax, if required. Right Fax v9.3 is used and the Right Fax radio button is selected by default. Select Fax Senior, if required. Enter the Fax Senior Server name that the Fax Process will be using to submit faxes with. This field will only be enabled if the Task selected is either FAX or FAX STATUS. Enter the port number of the Fax Senior Server. This port is configured during the installation Fax Senior. If you are unsure what the port is, please see your System Administrator. This field will only be enabled if the task selected is either FAX or FAX STATUS. Enter the Network Path for the Shared folder created as part of the Argus Safety Service Installation. The path must be entered using the UNC format. Example: \\FAXSENIOR\AGFax. Enter the Local Path for the same folder as in the Network Dir field above. The Local Path is the full path on the Fax Senior Machine to the same path entered in the Network Dir field. Example: C:\FaxSnr\AGFax. Enter the Address of the Administrator that will receive the s in the event that Argus Safety Service can not access the Fax Server. Enter the Right Fax login name. Argus Safety Process Configuration 3-5

20 Understanding Tasks Item Password Description Enter the Right Fax password. Understanding Tasks The Task list in the Argus Process dialog lists the different items for which processes can be created. 3-6 Oracle Argus Safety Service Administrator's Guide

21 Understanding Tasks Task Descriptions Item Auto Accept E2B Reports Audit Log Export Audit Log Update AutoSignal Batch Report Generation Batch Memorized Reports Description When ESM Service receives incoming E2B reports and the Argus Console for the electronic recipient is configured to auto accept in Reporting Destination with the AGService Process, then AGService auto accepts the E2B reports. The process creates a case for Initial reports or updates the case for follow-up reports received in a Queue. After auto accept, the system moves the reports to "E2B Processed" screen and ESM Service generates an Acknowledgment. Argus Safety allows the export of Audit Data to a table in a format that is readable by a user. This process exports up to 2000 cases at a time. After 2000 cases have been exported, the process shuts down and starts again at the next scheduled interval. Argus Safety allows loading of data through database scripts. The Audit Log Update process updates the Audit Log based on the item stored in the queue. This process audits up to 500 audits in a row. After 500 Audits have been completed, the process shuts down and starts again at the next scheduled interval. Argus Safety allows the configuration of Signals. Signals can be used to detect events that can be configured using Advanced Conditions. Argus Safety Service will automatically check for triggered events and notify a selected user of the event. The Batch Report Generation process eliminates the process of a user having to manually generate a report during a case workflow. Rules can be setup in Argus to have reports automatically generated on a scheduled basis. Using this process speeds up day to day tasks for the end user by moving the Report Generation Load to the Argus Safety Server and off the Local Client or the Web Server. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum. The Batch Memorized Reports process allows users to have System Reports such as Case Listing Reports and Case Data Analysis Reports automatically-generated, based on a pre-configured report. Argus Safety Configuration Utilities \ Configuration \ Auto Signal menu Utilities \ Configuration \ Batch Reports menu Utilities \ Configuration \ Batch Reports menu Argus Safety Process Configuration 3-7

22 Understanding Tasks Item Batch Periodic Reports Batch Report Case Bulk Report Print Bulk Report Transmit E2B Description The Batch Periodic Reports process removes the need to remember to schedule, generate and submit IND, NDA and PSUR Reports. Periodic Reports can be automatically scheduled and generated on a schedule configured based on the License Award Date. Using this process also speeds up day to day tasks for the end user by moving the Report Generation Load to the Argus Safety Server and off the Web Server. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum. Batch Report Case allows users to run reports on a scheduled date. Argus Safety supports Bulk Submission of reports for Printing. The Bulk Report Print Process will automatically generate, submit (if the report has been marked for submission) and print reports based on the printer configured for submission users site. Using this process speeds up day to day tasks for the end user by moving the Report Generation and Printing Load to the Argus Safety Server and off the Web Server. This process prints up to 100 reports in a row. After 100 prints have been completed, the process shuts down and start again at the next scheduled interval. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First).The process processes 10,000 reports in a day at a minimum. When a user transmits an E2B Report from "Bulk Reporting" screen, this AGService generates the E2B Report, if not previously generated, and transmits the report to ESM Service. The ESM Service creates a report in the outgoing folder, depending on the configuration. Argus Safety Configuration Reports \ ICH PSUR Reports menu Reports \ IND Reports menu Reports \ NDA Reports menu Run At Options Bulk Report By Form 3-8 Oracle Argus Safety Service Administrator's Guide

23 Understanding Tasks Item Bulk Report Transmit Bulk Report Transmit Fax Note: If E2B Reports are going to be transmitted, the Bulk Report Transmit Fax process must be running. Argus Safety supports Bulk Submission of reports for ing. The Bulk Report Transmit Process will automatically generate, submit (if the report has been marked for submission) and reports based on the address configured for the Report Submission Authority. Using this process speeds up day-to-day tasks for the end user by moving the Report Generation and ing Load to the Argus Safety Server and off the Local Client. Argus Safety Web requires this to process s. This process s up to 100 reports in a row. After 100 s have been sent, the process shuts down and start again at the next scheduled interval. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum. Argus Safety supports Bulk Submission of reports for faxing. The Bulk Report Transmit Fax Process will automatically generate reports for Fax Submission via Fax Senior. Argus Safety Web requires this process to have the ability to fax. This process faxes up to 100 reports in a row. After 100 faxes have been completed, the process shuts down and starts again at the next scheduled interval. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First).The process processes 10,000 reports in a day at a minimum. Documentum Report Push Argus safety will allow the push of Expedited and Periodic Reports into the Documentum system. Expedited Reports are pushed upon marking the report as submitted. Periodic Reports are pushed when they are generated in Argus. Once the Periodic Report has been marked as submitted, the process will update the status of the report within the Documentum database. Dossier Notification Fax Description After a PSUR report is generated and if Dossier is enabled, this process sends s to all users who are members of groups with assigned roles for periodic reports. The Fax Process will automatically transmit fax reports processed by the Bulk Report Transmit Fax Process to Omtool Fax Senior for Submission. Argus Safety Configuration Bulk Report By Form Bulk Report By Form Argus Safety Process Configuration 3-9

24 Understanding Tasks Item Fax Status Forced Report General Case Data Update General General Fax Letter Generation Local Labeling Report Scheduling Priority Description The Fax Status Process will continuously check for the status of the Fax Submission to update Argus Information. This process is required to be running if the Bulk Report Transmit Fax Process is enabled. When forced reporting is configured, this AG Service sends out forced expedited reports, based on configured reporting rules. This task has a dependency on the Scheduling Check task, so both must be configured. This service applies changes to cases based on XML from RPT_CASE_DELTA_ MESSAGE. Bulk Report Transmit and Bulk Report Transmit Fax use this service to mark the sent date of letters. This process sends all the Workflow Routing s which can be configured within the Workflow Configuration. It also sends all the Investigator Alert s which can be configured within the Study Configuration as defined in the Investigator Group configuration. This service is used when a fax service is configured to transmit faxes. It transmits pending faxes in the queue of faxes that are waiting to be sent. When letters are configured to be sent based on the case data and configured criteria, this service auto generates letters from cases where the Contact Date has been reached. The Local Labeling Report Scheduling process automatically schedules reports based on the Regulatory Rules configured in Argus for licenses that are marked as processed from the Local Labeling dialog. Report Scheduling occurs in the order of the Case Master Follow up Date or the Initial Receipt Date if Follow up is null. This is in ascending order of the Aware Date of the case. The Priority Process re-assesses all case priorities based on the Priority rule configuration in Argus. Using this process prevents cases from being reported on late by escalating the priority of the case which is visible by the users on the Argus Worklist, Case Form and other areas. In addition to raising priority, an escalation will be sent to the supervisor of the group if a case is not routed to the next workflow state within a specified amount of time configured in the Workflow Rules. Argus Safety Configuration Utilities \ Configuration \ Priority menu Utilities \ Configuration \ Workflow menu 3-10 Oracle Argus Safety Service Administrator's Guide

25 Configuring Argus Safety Process Item Report Scheduling Scheduling Check Description The Report Scheduling process automatically schedules reports based on Regulatory Rules configured in Argus for new cases. In addition, cases requiring follow-up reports are also evaluated. Priority for new cases entered into the system is assessed from the Report Scheduling Process. After the Initial Assessment, the PRIORITY process will reassess the priority based on changes made to the case if the process is running. This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First).The process processes 10,000 reports in a day at a minimum. Argus Safety will allow forecasting of reports that may be due within a specified amount of time for cases that have not been locked and do not have reports scheduled. Argus Safety Configuration Utilities \ Configuration \ Reporting Rules menu Note: When Argus Safety Service sends an to the local client or print job to Adobe Acrobat, it marks the report as "Success". If the client fails to send the to the Server or the OS fails to print the report to the printer due to network issues or configuration issues outside of Argus, the status will not be changed to "FAILED". It is prudent to add a manual process to confirm that the client and print queue outside Argus Safety Service are functioning on an on-going basis. Configuring Argus Safety Process Execute the steps below to configure an Argus Safety process: 1. Open the Argus Safety Configuration utility from Start>Programs>Oracle>Argus Safety Service Configuration. 2. The Argus Safety Service dialog opens. Argus Safety Process Configuration 3-11

26 Configuring Argus Safety Process 3. Open the Argus Process dialog box Oracle Argus Safety Service Administrator's Guide

27 Configuring Argus Safety Process Note: To remove an existing Argus Safety Service process, right-click the process and select Remove. 4. Enter the items in the Argus Process dialog. 5. Click OK. Argus Safety Process Configuration 3-13

28 Configuring Argus Safety Process 3-14 Oracle Argus Safety Service Administrator's Guide